Services

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Regulatory Affairs guidance, creation and filing of all types of submissions for drugs, Natural Health Products and medical devices in Canada  including:

• Regulatory Filing Strategy 
• Due Diligence and Regulatory Gap Analysis
• Pre-submission meetings with Health Canada (TPD and BGTD) 
• Preparation of Submissions: New Drug Submissions (NDS & ANDS), Supplemental New Drug Submissions (SNDS &ASNDS), Notifiable Changes (NC), Annual Notifications, Annual DIN Renewals, Drug Identification Number (DINs) 
• Label Negotiations with Health Canada
• Clinical Trial Applications for drugs and Medical Devices 
• CPP and CEP 
• Label Creation and Review ( pre and post approval)

• Review of advertising (Patient/Healthcare) and promotional materials (digital, print, sales detail aids) to ensure compliance to Canadian advertising regulations and PAAB guidelines

• Creation and review of GMP SOP’s 
• Drug Establishment Licence (DEL), Medical Device Establishment Licence (MDEL) and Site License applications and submissions 
• Assistance with and Hosting of Health Canada GMP Audits 
• GMP Compliance Gap Analysis 
• Production Records Review and Product Release for Canadian Market
• Distribution channels' alignment with Canadian GMP guidelines
• Creation of Quality Agreements with suppliers and third party logistics vendors
• Inspection readiness